Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Unit Dose Services
ALBUTEROL SULFATE
ALBUTEROL 2.5 mg in 3 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION UNIT DOSE SERVICES ---------- ALBUTEROL SULFATE INHALATION SOLUTION ALBUTEROL SULFATE INHALATION SOLUTION 0.083%* (*POTENCY EXPRESSED AS ALBUTEROL, EQUIVALENT TO 3 MG ALBUTEROL SULFATE) PRESCRIBING INFORMATION FOR INHALATION USE ONLY-NOT FOR INJECTION. DESCRIPTION: Albuterol sulfate inhalation solution is a relatively selective beta -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α -[(_tert_-Butylamino)methyl]-4- hydroxy-_m_-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula: Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C H NO ) • H SO . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Sulfate Inhalation Solution 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Sulfate Inhalation Solution 0.083% contains no sulfiting agents or preservatives. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. CLINICAL PHARMACOLOGY: The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. _In vitro_ studies and _in vivo_ pharmacologic studies have demonstrated that albuterol has a preferential effect on beta -adrenergic receptors compared with isoproterenol. While it is recognized that beta -adrenergic receptors are the predominant receptors in bronchial smooth muscle, 10% to 5 Citiți documentul complet